NDC | 57337-037-01, 57337-037-02 |
Set ID | 8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc |
Category | HUMAN OTC DRUG LABEL |
Packager | Rejoice International |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART347 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
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INACTIVE INGREDIENT
Inactive Ingredients water, paraffinum liquidum, isopropyl myristate, glycerin, glyceryl stearate, propylene glycol, PEG-100 stearate, polyacrylamide, cetyl alcohol, avena sativa kernel extract, fragrance, DMDM hydantoin, stearyl alcohol, c13-14 isoparaffin, laureth-7, disodium EDTA, methylparaben, propylparaben.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XTRACARE SKIN RELIEF OATMEAL DAILY MOISTURIZING
dimethicone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57337-037 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 5 mg in 354 mg Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) MINERAL OIL (UNII: T5L8T28FGP) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEG-100 STEARATE (UNII: YD01N1999R) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) CETYL ALCOHOL (UNII: 936JST6JCN) OAT (UNII: Z6J799EAJK) DMDM HYDANTOIN (UNII: BYR0546TOW) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) EDETATE DISODIUM (UNII: 7FLD91C86K) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57337-037-01 354 mg in 1 BOTTLE; Type 0: Not a Combination Product 11/26/2013 2 NDC:57337-037-02 227 mg in 1 BOTTLE; Type 0: Not a Combination Product 11/26/2013 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/26/2013 Labeler - Rejoice International (078741245) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp 529287434 manufacture(57337-037)